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    Chemistry

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    Also known as: E5501 maleate, 677007-74-8, Avatrombopag maleate [usan], Avatrombopag meleate, Avatrombopag (maleate), Gdw7m2p1is
    Molecular Formula
    C33H38Cl2N6O7S2
    Molecular Weight
    765.7  g/mol
    InChI Key
    MISPBGHDNZYFNM-BTJKTKAUSA-N
    FDA UNII
    GDW7M2P1IS
    Avatrombopag Maleate
    Avatrombopag Maleate is the maleate salt form of avatrombopag, an orally available platelet thrombopoietin receptor (TPOR; MPL) agonist, with potential megakaryopoiesis stimulating activity. Upon administration, avatrombopag binds to and stimulates TPOR, which may lead to the proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. This increases the production of platelets and may prevent chemotherapy-induced thrombocytopenia (CIT). TPOR is a cytokine receptor and member of the hematopoietin receptor superfamily.
    1 2D Structure

    Avatrombopag Maleate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (Z)-but-2-enedioic acid;1-[3-chloro-5-[[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)-1,3-thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic acid
    2.1.2 InChI
    InChI=1S/C29H34Cl2N6O3S2.C4H4O4/c30-20-15-23(41-17-20)24-27(37-12-10-35(11-13-37)21-4-2-1-3-5-21)42-29(33-24)34-26(38)19-14-22(31)25(32-16-19)36-8-6-18(7-9-36)28(39)40;5-3(6)1-2-4(7)8/h14-18,21H,1-13H2,(H,39,40)(H,33,34,38);1-2H,(H,5,6)(H,7,8)/b;2-1-
    2.1.3 InChI Key
    MISPBGHDNZYFNM-BTJKTKAUSA-N
    2.1.4 Canonical SMILES
    C1CCC(CC1)N2CCN(CC2)C3=C(N=C(S3)NC(=O)C4=CC(=C(N=C4)N5CCC(CC5)C(=O)O)Cl)C6=CC(=CS6)Cl.C(=CC(=O)O)C(=O)O
    2.1.5 Isomeric SMILES
    C1CCC(CC1)N2CCN(CC2)C3=C(N=C(S3)NC(=O)C4=CC(=C(N=C4)N5CCC(CC5)C(=O)O)Cl)C6=CC(=CS6)Cl.C(=C\C(=O)O)\C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    GDW7M2P1IS
    2.3 Synonyms
    2.3.1 Depositor-Supplied Synonyms

    1. E5501 Maleate

    2. 677007-74-8

    3. Avatrombopag Maleate [usan]

    4. Avatrombopag Meleate

    5. Avatrombopag (maleate)

    6. Gdw7m2p1is

    7. E-5501 Maleate

    8. (z)-but-2-enedioic Acid;1-[3-chloro-5-[[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)-1,3-thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic Acid

    9. 4-piperidinecarboxylic Acid, 1-(3-chloro-5-(((4-(4-chloro-2-thienyl)-5-(4-cyclohexyl-1- Piperazinyl)-2-thiazolyl)amino)carbonyl)-2-pyridinyl)-, (2z)-2-butenedioate (1:1)

    10. Unii-gdw7m2p1is

    11. Doptelet (tn)

    12. Akr-501 Monomaleate

    13. Chembl2105758

    14. Schembl19610454

    15. Avatrombopag Maleate [mi]

    16. Avatrombopag Maleate (jan/usan)

    17. Avatrombopag Maleate [jan]

    18. Dtxsid001027855

    19. 677007-74-8 (maleate)

    20. Hy-13463a

    21. Avatrombopag Maleate [who-dd]

    22. Avatrombopag Maleate [orange Book]

    23. Cs-0025423

    24. D10307

    25. A902459

    26. Q27279052

    27. 1-(3-chloro-5-((4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)thiazol-2- Yl)carbamoyl)pyridin-2-yl)piperidine-4-carboxylic Acid Mono-(2z)-but-2-enedioate

    28. 1-[3-chloro-5-[[4-(4-chlorothiophen-2-yl)-5-(4-cyclohexylpiperazin-1-yl)-1,3-thiazol-2-yl]carbamoyl]pyridin-2-yl]piperidine-4-carboxylic Acid;avatrombopag

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 765.7 g/mol
    Molecular Formula C33H38Cl2N6O7S2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count9
    Exact Mass764.1620453 g/mol
    Monoisotopic Mass764.1620453 g/mol
    Topological Polar Surface Area233 Ų
    Heavy Atom Count50
    Formal Charge0
    Complexity1050
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Indication

    Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.

    Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e. g. corticosteroids, immunoglobulins).

    Treatment of Idiopathic Thrombocytopenia Purpura (ITP), Treatment of Thrombocytopenic Purpura Secondary to Liver Disease

    5 Pharmacology and Biochemistry
    5.1 ATC Code

    B02BX

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    [{"dataSource":"API Export","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1632162600,"product":"AVATROMBOPAG STAGE-II","address":"PLOT NO.135, DR.NO.10-153\/1,","city":"VISAKHAPATNAM, ANDHRA PRADESH","supplier":"EISAI","supplierCountry":"INDIA","foreign_port":"NARITA APT\/TOKYO","customer":"EISAI","customerCountry":"JAPAN","quantity":"47.00","actualQuantity":"47","unit":"KGS","unitRateFc":"4971.5","totalValueFC":"230941.3","currency":"USD","unitRateINR":361430.27659574465,"date":"21-Sep-2021","totalValueINR":"16987223","totalValueInUsd":"230941.3","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29341000","bill_no":"4001025","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"JAPAN","selfForZScoreResived":"Pharma Grade","supplierPort":"Vizag-RPCIPL SEZ","supplierAddress":"PLOT NO.135, DR.NO.10-153\/1,, VISAKHAPATNAM, ANDHRA PRADESH","customerAddress":""}]
    21-Sep-2021
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    Drugs in Development

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    Gyre Therapeutics Gets NMPA Approval for Avatrombopag in CLD-Associated Thrombocytopenia

    Details:

    Avatrombopag Maleate, a thrombopoietin receptor agonist is approved by NMPA china. It is given orally for the treatment of thrombocytopenia associated with chronic liver disease.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Hematology Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Nanjing Healthnice Pharmaceutical Technology

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 02, 2024

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Hematology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Nanjing Healthnice Pharmaceutical Technology

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Gyre Therapeutics Gets NMPA Approval for Avatrombopag in CLD-Associated Thrombocytopenia

    Details : Avatrombopag Maleate, a thrombopoietin receptor agonist is approved by NMPA china. It is given orally for the treatment of thrombocytopenia associated with chronic liver disease.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 02, 2024

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    Health Canada Approves DOPTELET (avatrombopag) for Two Indications in Thrombocytopenia

    Details:

    DOPTELET® (avatrombopag maleate), an oral thrombopoietin receptor agonist, which is indicated for the of thrombocytopenia and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an invasive procedure.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Immunology Brand Name: Doptelet

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 06, 2023

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Health Canada Approves DOPTELET (avatrombopag) for Two Indications in Thrombocytopenia

    Details : DOPTELET® (avatrombopag maleate), an oral thrombopoietin receptor agonist, which is indicated for the of thrombocytopenia and for the treatment of severe thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo an...

    Brand Name : Doptelet

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 06, 2023

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    Sobi at EHA Virtual Congress 2021: Focus on Results in Pnh and Treatment for ITP

    Details:

    PEGASUS evaluated the efficacy and safety of pegcetacoplan in adult patients with suboptimal response to prior treatment with eculizumab.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Immunology Brand Name: Doptelet

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable June 01, 2021

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sobi at EHA Virtual Congress 2021: Focus on Results in Pnh and Treatment for ITP

    Details : PEGASUS evaluated the efficacy and safety of pegcetacoplan in adult patients with suboptimal response to prior treatment with eculizumab.

    Brand Name : Doptelet

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    June 01, 2021

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    Sobi Gets EU Approval Doptelet® (Avatrombopag) for treatment of ITP

    Details:

    Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Immunology Brand Name: Doptelet

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 20, 2021

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Immunology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sobi Gets EU Approval Doptelet® (Avatrombopag) for treatment of ITP

    Details : Doptelet is an orally administered thrombopoietin receptor agonist (TPO-RA) that mimics the biologic effects of TPO in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count.

    Brand Name : Doptelet

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 20, 2021

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    Sobi Launch Doptelet® (Avatrombopag) in Europe

    Details:

    Doptelet (avatrombopag) is designed to mimic the biologic effects of thrombopoietin in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count, according to Sobi.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Hematology Brand Name: Doptelet

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 04, 2020

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    Swedish Orphan Biovitrum AB

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Hematology

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sobi Launch Doptelet® (Avatrombopag) in Europe

    Details : Doptelet (avatrombopag) is designed to mimic the biologic effects of thrombopoietin in stimulating the development and maturation of megakaryocytes, resulting in increased platelet count, according to Sobi.

    Brand Name : Doptelet

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 04, 2020

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    Sobi Announces Topline Phase 3 Data of Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia

    Details:

    Though avatrombopag increased platelet counts relative to placebo as expected, the study did not meet the composite primary endpoint of avoiding platelet transfusions, chemotherapy dose reductions by 15 per cent or greater, and chemotherapy dose delays by four days or more.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Hematology Brand Name: Doptelet

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 09, 2020

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Hematology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Sobi Announces Topline Phase 3 Data of Avatrombopag for the Treatment of Chemotherapy-Induced Thro...

    Details : Though avatrombopag increased platelet counts relative to placebo as expected, the study did not meet the composite primary endpoint of avoiding platelet transfusions, chemotherapy dose reductions by 15 per cent or greater, and chemotherapy dose delays b...

    Brand Name : Doptelet

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 09, 2020

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    Dova Granted Orphan Drug Designation for Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia

    Details:

    Enrollment remains ongoing for the phase 3 clinical study of avatrombopag for the treatment of patients with CIT.


    Lead Product(s): Avatrombopag Maleate

    Therapeutic Area: Hematology Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 13, 2020

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    Dova Pharmaceuticals

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    Lead Product(s) : Avatrombopag Maleate

    Therapeutic Area : Hematology

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Dova Granted Orphan Drug Designation for Avatrombopag for the Treatment of Chemotherapy-Induced Th...

    Details : Enrollment remains ongoing for the phase 3 clinical study of avatrombopag for the treatment of patients with CIT.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 13, 2020

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    Regulatory Info : RX

    Registration Country : USA

    AVATROMBOPAG MALEATE

    Brand Name : DOPTELET

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 20MG BASE

    Packaging :

    Approval Date : 2018-05-21

    Application Number : 210238

    Regulatory Info : RX

    Registration Country : USA

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    Regulatory Info :

    Registration Country : Switzerland

    Avatrombopagum

    Brand Name : Doptelet

    Dosage Form : Filmtabl

    Dosage Strength : 20mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

    Avatrombopagum

    Brand Name : Doptelet

    Dosage Form : Filmtabl

    Dosage Strength : 20mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

    Avatrombopagum

    Brand Name : Doptelet

    Dosage Form : Filmtabl

    Dosage Strength : 20mg

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    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Australia

    avatrombopag

    Brand Name : Doptelet

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    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    avatrombopag

    Brand Name : Doptelet

    Dosage Form :

    Dosage Strength :

    Packaging : 30

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Europe

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    Regulatory Info :

    Registration Country : Switzerland

    Avatrombopagum

    Brand Name : Doptelet

    Dosage Form : Filmtabl

    Dosage Strength : 20mg

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    Regulatory Info :

    Registration Country : Switzerland

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    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Doptelet

    Dosage Form : Filmtabl

    Dosage Strength : 20mg

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    Approval Date :

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    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Doptelet

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    Dosage Strength : 20mg

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    Approval Date :

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    Regulatory Info :

    Registration Country : Switzerland

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    01

    AKARX INC

    AVATROMBOPAG MALEATE

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    AKARX INC

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    Patent Expiration Date : 2027-07-28

    AVATROMBOPAG MALEATE

    US Patent Number : 7638536

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 210238

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2027-07-28

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